PlainRecalls
FDA Drug Moderate Class II Terminated

Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL), 5 x 5 mL Pre-Filled Syringe, 6 x 5 syringe carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th Street Extension, West Columbia, SC 29172, NDC: 69374-924-05

Reported: January 18, 2023 Initiated: January 6, 2023 #D-0099-2023

Product Description

Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL), 5 x 5 mL Pre-Filled Syringe, 6 x 5 syringe carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th Street Extension, West Columbia, SC 29172, NDC: 69374-924-05

Reason for Recall

Lack of Assurance of Sterility

Details

Units Affected
38,830 syringes
Distribution
Nationwide in the USA.
Location
West Columbia, SC

Frequently Asked Questions

What product was recalled?
Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL), 5 x 5 mL Pre-Filled Syringe, 6 x 5 syringe carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th Street Extension, West Columbia, SC 29172, NDC: 69374-924-05. Recalled by Nephron Sterile Compounding Center LLC. Units affected: 38,830 syringes.
Why was this product recalled?
Lack of Assurance of Sterility
Which agency issued this recall?
This recall was issued by the FDA Drug on January 18, 2023. Severity: Moderate. Recall number: D-0099-2023.